Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
30 participants
OBSERVATIONAL
2019-09-27
2022-07-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry
NCT04600102
Improving the Detection, Classification and Treatment of Misaligned Arthritic Ankles
NCT03440008
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
NCT03575975
3D Multisegment Foot Model Used for the Clinical Outcome After Ankle and Hindfoot Reconstruction
NCT04822558
Clinical Efficacy of a 3D Foot Scanner for the Therapeutic Footwear Fitting
NCT05353114
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators will obtain a brief medical history to identify major medical conditions or prior injuries that could influence limb geometry, and lead to reliance on an AFO for Group 2 participants.
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed. Measurements will be evaluated using digital imaging analysis software (Standard Cyborg, Inc.). The investigators will evaluate concurrent validity by directly comparing software-based measurements from limb scans, with direct measurements on the same individual collected using digital calipers. The investigators will determine repeatability of each technique by conducting three identical limb scans and actual physical measurements at two time points on the same day in each individual, and then comparing the results between time points. The interior of the AFO worn by participants in Group 2 will also be scanned to obtain its geometry for comparison with measurements obtained from each individual's limb.
Validity and repeatability will be assessed using measurements at multiple locations on the lower leg. Limb measurements will include 1) width of the metatarsal heads, 2) width of the calcaneus, 3) foot length, 4) foot height, 5) arch height, 6) medial-lateral width between ankle malleoli, 7) minimum circumference above the ankle malleoli, 8) maximum calf circumference , 9) medial-lateral width of the knee condyles 10) anterior-posterior width at mid patellar tendon, 11) distance from bottom of foot to tibial tubercle.
Concurrent validity will be determined using the intra-class correlation coefficient and absolute error (root mean square error) for comparisons between measurements from limb scanning and the calipers. Reliability will be determined using the intra-class correlation coefficient and the minimal detectable change value for comparisons over time.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Healthy Able-bodied Individuals
Healthy able-bodied individuals with no history of lower extremity trauma.
Structure Sensor
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.
Caliper
Caliper: An OriginCal IP54 digital caliper (Anytime Inc, Granada Hills, CA) was used to take three consecutive physical measurements in millimeters at each identified measurement location. For measurements outside of the caliper's scope a tape measure was used in place of the caliper. Physical measuring devices were reset to zero between each measure.
Group 2: Individuals Requiring AFO Use
Individuals with unilateral, below knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).
Structure Sensor
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.
Caliper
Caliper: An OriginCal IP54 digital caliper (Anytime Inc, Granada Hills, CA) was used to take three consecutive physical measurements in millimeters at each identified measurement location. For measurements outside of the caliper's scope a tape measure was used in place of the caliper. Physical measuring devices were reset to zero between each measure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Structure Sensor
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.
Caliper
Caliper: An OriginCal IP54 digital caliper (Anytime Inc, Granada Hills, CA) was used to take three consecutive physical measurements in millimeters at each identified measurement location. For measurements outside of the caliper's scope a tape measure was used in place of the caliper. Physical measuring devices were reset to zero between each measure.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy individuals without a current complaint of lower extremity pain, spine pain, active infections or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
* Ability to perform a full squat without pain
* Able to read and write in English and provide written informed consent
* Ages: 18-75
* Daily AFO use to address unilateral below knee functional deficits (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease)
* Ability to stand independently without use of an assistive device (Cane, crutch, etc)
* Ability to safely bear full body weight on affected limb without use of an AFO or other protection
* Able to read and write in English and provide written informed consent
Exclusion Criteria
* Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
* Current complaint of pain or numbness in the spine
* Uncorrected visual or hearing impairments that limit the ability to understand or comply with instructions given during testing
* Require an assistive device
* Open/unhealed wounds on lower extremity.
* BMI greater than 35
GROUP 2
* Use of an AFO that crosses the knee (includes Knee brace or similar)
* Open/unhealed wounds on lower extremity
* Uncorrected visual or hearing impairments that limit the ability to understand or comply with instructions given during testing
* BMI greater than 35
* Diagnoses of a moderate to severe brain injury
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Iowa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jason Wilken
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jason M Wilken, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa
Iowa City, Iowa, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201905871
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.